Effect of Dexamethasone as an Adjuvant to Bupivacaine in Bilateral Erector Spinae Block on Postoperative Pain and Diaphragmatic Function After Pediatric Cardiac Surgeries : A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 主要终点
- postoperative pain, Face, Legs, Activity, Cry and Consolability (FLACC) pain scale
研究概览
简要总结
The aim of this study is to figure out the efficacy of dexamethasone addition to bupivacaine versus bupivacaine alone in bilateral erector spinae plane block on postoperative analgesia after pediatric cardiac surgeries
详细描述
The recently introduced ultrasound-guided interfascial plane block, bilateral erector spinae plane block (ESPB) is a viable option for management of postoperative pain after midline sternotomy. It is expected to provide an analgesic cover spanning the entire thorax at the desired dermatomes including the midline, which could prove beneficial for cardiac surgery through midline sternotomy.
Indications for ESPB for postoperative analgesia in pediatric surgeries to date include thoracotomy, video-assisted thoracoscopic surgery, vascular ring repair and sternotomy.
Dexamethasone is a synthetic glucocorticoid acting as an anti- inflammatory. It inhibits the release of inflammatory mediators such as interleukins and cytokines. Several studies have shown that a preoperative dose of dexamethasone added to local anesthetic agents has promising results in reducing postoperative pain and improving the quality of analgesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I and II
- •Undergoing cardiac surgical procedures through a midline sternotomyPreoperative ejection fraction <35%
排除标准
- •Low-cardiac-output syndrome
- •Ventricular arrhythmia
- •Preoperative inotropic support
- •Known allergies to any of the study drugs
- •Intubation for more than 3 hours or re-exploration
- •A redo or emergency surgery
- •Contraindications to regional anesthesia as coagulopathy and infection in site of block.
结局指标
主要结局
postoperative pain, Face, Legs, Activity, Cry and Consolability (FLACC) pain scale
时间窗: Postoperative pain assessment is performed using FLACC pain scale at fixed time intervasl for 48 hours post extubation,
The primary outcome of this study is the intensity of postoperative pain that will be assessed using Face, Legs, Activity, Cry and Consolability, minimum value 0 and maximum value 10, high scores means worse outcome (FLACC) pain scale
次要结局
- total analgesic consumption postoperative(for 48 hours postextubation)
研究者
Amonios khalil
assistant lecturer at anaesthesia and ICU department
Assiut University